Manager* IMP GMP/GCP Compliance

  • Cambridge, Massachusetts
  • Work experience
  • Transport
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Manager* IMP GMP/GCP Compliance

 Your main responsibilities are:
  • Represents CTSM in setup of processes with internal and external CMO's including generation & maintenance of knowledge about CMOs' offered processes
  • Reviews, aligns, and provides input and maintains QAAs for internal and external CMO
  • Provides input into Certification and Release Strategy for trial (e.g., QP declaration, Sponsor release)
  • Represents CTSM as expert on DP manufacturing activities
  • Liaises with GMP QA and other relevant cross functional interfaces and supports on CTSM GMP related activities
  • Liaises with Logistics to plan return process
  • Liaises with IMP Manager to define P&L requirements for trial and conduct P&L planning with vendors
  • Supports on appropriate CTSM GMP risk communication and ensures CTSM GMP requirements are met
  • Generates/coordination of labels for study drugs ensuring agreed milestones, quality and costs are met
  • Coaching

What you have to offer.

  • University degree in Engineering, Supply Chain Management or related discipline
  • Multiple years of work experience in Clinical Supply in Pharmaceutical or Biotech Industry setting or other relevant professional experience in Packaging and Labeling
  • Proven track record of supply chain and study drug logistics (set up and management) in global clinical trials up to Phase III
  • Deep Knowledge about GMP Principles (SOPs, Documentation, etc.) and Deep Understanding of Quality Management Systems
  • Advanced knowledge in preparing for and participating in audits and inspections
  • Understanding of Planning & Scheduling processes
  • Knowledge about contract settings
  • Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
  • Effective stakeholder management

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location  and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 7546 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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